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Regulatory

Latest Headlines

Latest Headlines

CMS, hospitals rail against update to FDA device safety reports amid duodenoscope pushback

Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.  

NICE, in reversal, OKs Amgen's Repatha while snubbing Sanofi and Regeneron's Praluent

Amgen's Repatha is in a market brawl with Sanofi and Regeneron's Praluent as the competitors rush to sew up as many OKs around the world as possible for the new-gen cholesterol fighters following their FDA approval last year within weeks of one another. Now Amgen has pulled ahead in England after the country's drug pricing watchdog has both changed course to cover Repatha for some patients, while dealing its competitors a blow with a rejection for Praluent.

Sarepta faces another FDA delay with its much-scrutinized DMD drug

Sarepta Therapeutics, hoping to win approval with a treatment for Duchenne muscular dystrophy, will have to endure a three-month FDA delay before getting final word on its drug.

Omega diet-aid ad banned in U.K.; summer slimming promos not 'socially responsible'

Omega Pharma's advertising for its diet pill XLS Medical found itself in the middle of a dust-up in Britain, with hundreds of complaints flying about the swimsuit-season promos. And now, the campaign is banned altogether.

Baxalta partner CTI plunges after FDA slaps partial hold on PhIII myelofibrosis drug

The FDA has slapped a partial clinical hold on CTI BioPharma's late-stage myelofibrosis drug pacritinib after patients in the drug arm of a Phase III study began to die at a higher rate than those in the placebo group. The drug arm also registered a higher number of adverse events, further raising concerns about the safety of the drug.

Novo says China price pressures may go into 2017

With approval for Tresiba in China potentially years out, Novo Nordisk expects continued price competition from domestic companies that will show up on the books more widely in the coming year and into 2017.

EMA: Faulty device didn't distort study findings for Bayer's Xarelto

Last December, European regulators said they were no longer sure whether results from a trial of Bayer's new-age clot-buster Xarelto were accurate thanks to a defect in a blood-clotting testing device used in the study. But the German pharma can breathe easy now.

Celltrion's take on J&J's Remicade is 'highly similar' to the original, FDA says

FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer to tap the U.S. market.

Celltrion's biosimilar of J&J's Remicade reviewed favorably by FDA staffers

FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency. 

FDA shoots down Vertex's latest bid for Kalydeco expansion

Vertex has so far had a lot of success widening the patient pool for orphan drug Kalydeco. But in its latest quest for a label expansion, the FDA has stopped it in its tracks.